A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder

NCT03632356 | Unknown

• 1 other identifier: 2018/2284
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Using a randomized controlled trial (RCT) design, the main objective of this study is to evaluate the clinical, patient-centered, and economic effectiveness of a stepped-care intervention for patients with panic attacks and panic disorder presenting to the busiest Accident and Emergency (A\&E) departments of the largest public healthcare group in Singapore. The RCT will have two arms: 1) treatment via an enhanced care pathway consisting of a stepped-care intervention for panic attacks and panic disorder; and 2) a control arm consisting of screening for panic attacks and panic disorder in the A\&E and discharge (routine care). In addition to the baseline assessment, the study follow-up visits will occur at 1, 3, 6, and 12 months.

Conditions

Panic Attacks and Disorders

Outcome Measures

Primary Outcomes (1)

• Change in panic scores at every 3 months from baseline using the Panic Disorder Severity Scale (PDSS; Shear et al., 2001)

  The PDSS is a 7-item semi-structured interview of panic symptom severity. Each item is rated on a 0 (none/mild) to 4 (extreme/severe) scale. A higher total score would represent severe panic symptoms.

  Baseline, 1st month, 3rd month, 6th month, 12th month

Secondary Outcomes (4)

• Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)

  Baseline, 1st month, 3rd month, 6th month, 12th month

• WHO Disability Assessment Schedule (WHO-DAS; World Health Organization, 2010)

  Baseline, 1st month, 3rd month, 6th month, 12th month

• Psychiatric Diagnostic Screening Questionnaire (PDSQ; Zimmerman & Mattia, 2001)

  Baseline, 1st month, 3rd month, 6th month, 12th month

• EQ-5D (EuroQol Group, 1990)

  Baseline, 1st month, 3rd month, 6th month, 12th month

Other Outcomes (2)

• Clinician Global Impression Severity Scale (CGI; Guy, 2008)

  Baseline, 1st month, 3rd month, 6th month, 12th month

• Panic Disorder Module of the Structured Clinical Interview for DSM-5 (SCID; First et al., 2015)

  Baseline, 1st month, 3rd month, 6th month, 12th month

Study Arms (2)

Stepped Care Intervention (STEP)

EXPERIMENTAL

In a stepped-care model, all patients start with an evidence-based intervention of low intensity as a first treatment step. Progress is monitored and patients who do not respond adequately can subsequently be 'stepped up' to a higher intensity treatment. This model is now being recommended as the best strategy for treating panic attacks and panic disorder.

Behavioral: Stepped Care Intervention (STEP)

Screening only

ACTIVE COMPARATOR

Screening only for panic attacks and panic disorder using a gold standard clinical interview that provides coverage of the core symptoms of panic attacks and panic disorder.

Diagnostic Test: Screening only

Interventions

Stepped Care Intervention (STEP) BEHAVIORAL

A stepwise progression of intervention according to the participant's response to the increasing levels of therapy. There will be 1 session of psychoeducation, followed by 5 sessions of Cognitive Behavioral Therapy (CBT) if panic symptoms do not improve at 1-month follow-up.

Stepped Care Intervention (STEP)

Screening only DIAGNOSTIC_TEST

Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5

Screening only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• + years of age
• Triage level 2 or 3
• English or Mandarin speaking
• Able to provide informed consent and read study materials
• Presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing
• Score ≥ 3 on CDR screener
• Diagnosis of panic attack or panic disorder confirmed on SCID interview
• Willing to enter randomized trial

You may not qualify if:

• Altered mental status (dementia, psychosis, substance intoxication/withdrawal)
• Triage level 1
• Non-English or Mandarin speaking
• Unwilling or unable to complete study procedures
• Symptoms of clear cardiac origin as determined by A\&E physician
• Deemed unfit due to possible adverse respiratory or cardiac outcomes by A\&E physician
• Clear organic cause for panic symptoms as evidenced by laboratory tests (FBC, UE, ECG, TROPONIN T, CXR)
• Does not meet criteria for panic attack or panic disorder on SCID interview
• Received CBT for panic symptoms in previous 12 months

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Changi General Hospital: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (9)

• Shear MK, Rucci P, Williams J, Frank E, Grochocinski V, Vander Bilt J, Houck P, Wang T. Reliability and validity of the Panic Disorder Severity Scale: replication and extension. J Psychiatr Res. 2001 Sep-Oct;35(5):293-6. doi: 10.1016/s0022-3956(01)00028-0.

  PMID: 11591432 BACKGROUND

• Guy, W., Clinical Global Impressions (CGI) Scale., In: Rush, A. J., First, M. B. and Blacker, D. (eds), Handbook of Psychiatric Measures, Washington, D.C.: American Psychiatric Publishing, Inc., 2008.

  BACKGROUND

• First, M. B., Williams, J. B. W., Karg, R. S. and Spitzer, R. L., Structured Clinical Interview for DSM-5 Disorders-Clinician Version (SCID-5-CV), Arlington, VA: American Psychiatric Association, 2015.

  BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• World Health Organization, Measuring Health and Disability: Manual for WHO Disability Assessment Schedule - WHODAS 2.0, Geneva, 2010.

  BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Sung SC, Rush AJ, Earnest A, Lim LEC, Pek MPP, Choi JMF, Ng MPK, Ong MEH. A Brief Interview to Detect Panic Attacks and Panic Disorder in Emergency Department Patients with Cardiopulmonary Complaints. J Psychiatr Pract. 2018 Jan;24(1):32-44. doi: 10.1097/PRA.0000000000000283.

  PMID: 29320381 BACKGROUND

• Zimmerman M, Mattia JI. A self-report scale to help make psychiatric diagnoses: the Psychiatric Diagnostic Screening Questionnaire. Arch Gen Psychiatry. 2001 Aug;58(8):787-94. doi: 10.1001/archpsyc.58.8.787.

  PMID: 11483146 BACKGROUND

• Sung SC, Lim L, Lim SH, Finkelstein EA, Chin SLH, Annathurai A, Chakraborty B, Strauman TJ, Pollack MH, Ong MEH. Protocol for a multi-site randomized controlled trial of a stepped-care intervention for emergency department patients with panic-related anxiety. BMC Psychiatry. 2022 Dec 16;22(1):795. doi: 10.1186/s12888-022-04387-z.

  PMID: 36527018 DERIVED

MeSH Terms

Conditions

Panic Disorder; Disease

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon C Sung, PhD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 stage parallel group multi-site RCT design

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 15, 2018
• Study Start: June 11, 2018
• Primary Completion: May 31, 2024
• Study Completion: November 30, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)